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WEST-KOaST Study: WES Analysis of Testicular Cancer Patientsand Their First-degree Family Members

WEST-KOaST Study: WES (Whole Exome Sequencing) Analysis of Testicular Cancer Patientsand Their First-degree Family Members

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06142500
Acronym
West-KOaSt
Enrollment
4500
Registered
2023-11-21
Start date
2023-12-01
Completion date
2026-09-21
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Testicular Cancer

Keywords

testicular cancer, cancer, familiarity, genetic, male infertility

Brief summary

The project aims to identify the possible risk factors regarding the onset of the disease and to evaluate genes and gene modifications responsible for the onset od testicular cancer.

Detailed description

Testicular tumor represents a relatively rare disease that hit young-adults men. It represents 1% of all male cancers and 5% of all urological male tumors. Its incidence grow year by year. In the field of the oncological research, the lack of knowledge about genes related to this disease represent a very relevant clinical question. For this reason this project aims to collect biological samples of saliva from testicular cancer patients and from their first-degree family members; demographic-clinical variables will be also collected in order to draft a comprehensive panel of genes and gene modifications related to the testicular cancer, combining this survey with a very detailed description of this cohort of patient in terms of clinical features and quality of life.

Interventions

GENETICAnalysis of biological samples of saliva from testicular cancer patients and from their first-degree family members

The project aims to collect biological samples of saliva from testicular cancer patients and from their first-degree family members; demographic-clinical variables will be also collected in order to draft a comprehensive panel of genes and gene modifications related to the testicular cancer, combining this survey with a very detailed descprition of this cohort of patient in terms of clinical features and quality of life

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Male testicular cancer patients with an age \> 18 and \< 90 * First degree family members of Male testicular cancer patients with an age \> 18 and \< 90 * Ability to read and sign the informed consent * Diagnosis of testicular cancer for the experimental group

Exclusion criteria

* Female for the experimental group * Second degree family members of Male testicular cancer patients * People with an age \< 18 and \> 90 * Diagnosis different from testicular cancer for the experimental group Incapacity to read and sign the informed consent

Design outcomes

Primary

MeasureTime frameDescription
Saliva biological sampleBaselineSaliva biological samples will be collected from both patients with testicular cancer and their first-degree family members trough a buccal swab, that will be analysed with a whole exome sequencing (WES) in order to explore panel of genes

Secondary

MeasureTime frameDescription
Demographic-clinical variablesBaselineDemographic and clinical variables will be collected from the interview with the physician: 1)Age of the subject; 2. Age at diagnosis; 3. Ethnicity; 4.BMI; 5. Lifestyle (smoking, diet, alcohol, physical activity…); 6. Histotype of the neoplasm; 7; Nodule Size; Presence of embryonal carcinoma \> 50%; 8. Percentage of necrosis present; 9. Basic pharmacological therapy; 10. Chemo/radiotherapy;

Contacts

Primary ContactAndrea Salonia, MD
salonia.andrea@hsr.it+390226435661
Backup ContactAlessia d'Arma, MSc
darma.alessia@hsr.it02 2643 5506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026